Arthrex® AR-13400L-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867011731), received between Mar 27, 2019 and Mar 27, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 27, 2019Break; Detachment of Device or Device Component

  IT WAS DISCOVERED DURING MONTHLY MAUDE REVIEW THAT THE FOLLOWING INCIDENT WAS REPORTED TO THE FDA (MW5084048): DURING A PROCEDURE ON (B)(6) 2018 THE SCREW HEAD (AR-13400L-10, LOT 10129530) BROKE OFF IN THE TIBIA DURING THE PROCEDURE. IT WAS LEFT IN PLACE FOR STABILITY. DIAGNOSIS WAS AN ACL TEAR/LATERAL MENISCUS TEAR. NO FURTHER INFORMATION WAS PROVIDED ON THE MAUDE REPORT. THE ABOVE EVENT DESCRIPTION WAS ENTERED BY ARTHREX AS SHOWN ON THE MAUDE DATABASE. THIS EVENT DESCRIPTION MAY CONTAIN CLAIMS OR LANGUAGE FROM THE REPORTER/COMPLAINANT REGARDING ARTHREX DEVICE PERFORMANCE. SUCH CLAIMS HAVE NOT BEEN EVALUATED BY ANY ARTHREX PRODUCT EXPERTS. ARTHREX¿S INCLUSION OF ANY CLAIMS SHOULD NOT BE CONSTRUED AS ARTHREX EXPRESSING AGREEMENT WITH SUCH CLAIMS. THE MAUDE DATABASE DID NOT CONTAIN FACILITY/REPORTER INFORMATION AND THEREFORE AT THIS TIME NO FOLLOW UP CAN BE PERFORMED. IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE, THIS COMPLAINT WILL BE EVALUATED AS ALL COMPLAINTS ARE IN ACCORDANCE WITH ARTHREX COMPLAINT HANDLING PROCEDURES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8455883 ↗